Breast CarcinomaEVONAILNCT02870699
Efficacy of Evonail® Solution in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.
A study testing Evonail in people with Breast Carcinoma, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Evonail
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Patient with breast carcinoma
- Patients treated with adjuvant chemotherapy (FEC + 3 docetaxel +/- Herceptin®)
- Patients who have never been treated with taxanes
- Patients with no nail damage before starting the study
- ECOG performance < 2
- Ability to provide written informed consent
Who cannot join
- Patient allergic to any of the treatment components
- Use of film-forming solution, solvents or any other products applied to the fingernails (artificial nails ...) in three weeks before the first of docetaxel treatment
- Risk of exposure to aggressive factors nail during the study
- Using refrigerants gloves during chemotherapy treatments
- Onychophagia
- Presence of nail disease or a history of nail pathology (infectious and other)
- Pregnant or breast feeding females
- Patients whose condition is not compatible with the follow-up study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effectiveness of the Film-forming Solution Evonail® Versus Placebo in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.
Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events.
Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having nail damage.
The purpose of this study is to confirm the effectiveness of the film-forming solution Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.
- Conditions
- Breast Carcinoma
- Being tested
- Evonail, Placebo excipient
- Keywords
- chemotherapy neoadjuvant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvonailDevice
film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter
Placebo excipientDevice
film forming excipient solution
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | * Evonail film forming solution : 1 daily application on the left hand
* Placebo excipient : 1 daily application on the right hand Receives: Device: Evonail; Device: Placebo excipient |
| ARM B | Active comparator | * Evonail film forming solution : 1 daily application on the right hand
* Placebo excipient : 1 daily application on the left hand Receives: Device: Evonail; Device: Placebo excipient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the film-forming solution Evonail® versus placebo on nail damage
Efficacy will be evaluated by the oncologist according to NCI-CTC
Measured: up to 9 weeks
Secondary outcomes (3)
Different types of nail damage observed in each group after chemotherapy docetaxel
Nail damage will be evaluated by the dermatologist based on photography according to NCI-CTC
Measured: up to 9 weeks
Patient compliance for the film-forming solution Evonail®
Patient compliance will be evaluated using a questionnaire
Measured: up to 9 weeks
Patient satisfaction regarding the use of the film-forming solution Evonail®
Patient satisfaction will be evaluated using a questionnaire
Measured: up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startOct 2011
- Primary completionJun 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Collaborators
- Clinact
- Responsible party
- Sponsor
- Investigators
- UWER Lionel, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870699
- Sponsor's protocol ID
- 2011-A00981-40
- Acronym
- EVONAIL
- Status last verified
- Aug 2018
- First submitted
- 12 Aug 2016
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of the Film-forming Solution Evonail® Versus Placebo in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.
- ClinicalTrials.gov ID
- NCT02870699
- Acronym / sponsor ID
- EVONAIL / 2011-A00981-40
- Conditions
- Breast Carcinoma
- Keywords
- chemotherapy neoadjuvant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Collaborators
- Clinact
- Study start
- Oct 2011 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events.
Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having nail damage.
The purpose of this study is to confirm the effectiveness of the film-forming solution Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Device: Evonail, Device: Placebo excipient* Evonail film forming solution : 1 daily application on the left hand * Placebo excipient : 1 daily application on the right hand |
| ARM B | Active comparator | Device: Evonail, Device: Placebo excipient* Evonail film forming solution : 1 daily application on the right hand * Placebo excipient : 1 daily application on the left hand |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Patient with breast carcinoma
- Patients treated with adjuvant chemotherapy (FEC + 3 docetaxel +/- Herceptin®)
- Patients who have never been treated with taxanes
- Patients with no nail damage before starting the study
Key exclusion criteria (8 listed)
- Patient allergic to any of the treatment components
- Use of film-forming solution, solvents or any other products applied to the fingernails (artificial nails ...) in three weeks before the first of docetaxel treatment
- Risk of exposure to aggressive factors nail during the study
- Using refrigerants gloves during chemotherapy treatments
- Onychophagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evonailfilm-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter | Device | ARM A, ARM B |
| Placebo excipientfilm forming excipient solution | Device | ARM A, ARM B |
Primary outcome
Efficacy of the film-forming solution Evonail® versus placebo on nail damage
Time frame: up to 9 weeks
Efficacy will be evaluated by the oncologist according to NCI-CTC
3 secondary outcomes
Different types of nail damage observed in each group after chemotherapy docetaxel
Time frame: up to 9 weeks
Patient compliance for the film-forming solution Evonail®
Time frame: up to 9 weeks
Patient satisfaction regarding the use of the film-forming solution Evonail®
Time frame: up to 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UWER Lionel, MD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evonail in people with Breast Carcinoma, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the film-forming solution Evonail® versus placebo on nail damage (time frame: up to 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.